Ultrasound-Guided Platelet-Rich Plasma Versus Local Anesthetic Injection for Chronic Neuroma Pain After Combat-Related Amputation: A Prospective Multicenter Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 2
研究概览
简要总结
Patients with combat-related amputations frequently experience chronic neuroma pain that may interfere with rehabilitation, prosthesis use, mobility, sleep, and quality of life. Current treatment approaches often provide only temporary pain relief.
Platelet-rich plasma (PRP) has emerged as a potential regenerative treatment option because of its possible effects on tissue healing, neuroinflammation, and peripheral nerve irritation. However, its role in the treatment of chronic neuroma pain after amputation remains unclear.
This prospective multicenter controlled study aims to compare ultrasound-guided PRP injection around the neuroma with ultrasound-guided local anesthetic injection in patients with chronic neuroma pain after combat-related amputation.
Participants will undergo one of the two injection treatments and will be followed over time to evaluate changes in pain intensity, neuropathic pain symptoms, phantom limb pain, prosthesis tolerance, and functional outcomes.
The goal of the study is to evaluate the safety, feasibility, and potential clinical effectiveness of PRP injection for chronic neuroma pain following combat-related amputation.
详细描述
Chronic neuroma pain is a frequent and disabling complication following combat-related limb trauma and amputation. Persistent neuroma pain may contribute to residual limb pain, phantom limb pain, impaired prosthesis tolerance, sleep disturbance, reduced mobility, and decreased quality of life. Conventional treatment strategies, including local anesthetic injections, often provide only temporary pain relief and limited long-term functional improvement.
Platelet-rich plasma (PRP) has emerged as a potential regenerative treatment option because of its possible effects on tissue repair, neuroinflammation, peripheral sensitization, and scar-related nerve irritation. PRP contains multiple growth factors and bioactive molecules that may support peripheral nerve healing and modulation of chronic neuropathic pain mechanisms. However, evidence regarding PRP treatment for chronic neuroma pain after combat-related amputation remains limited.
This prospective multicenter controlled study is designed to compare ultrasound-guided PRP injection around the neuroma with ultrasound-guided local anesthetic injection in patients with chronic neuroma pain after combat-related amputation.
Patients with ultrasound-confirmed painful neuromas will undergo ultrasound-guided perineuroma injection using either PRP or local anesthetic according to the study protocol. All procedures will be performed under sterile conditions by clinicians experienced in ultrasound-guided pain interventions.
Clinical follow-up will include assessment of neuroma pain intensity, neuropathic pain characteristics, phantom limb pain, residual limb pain, prosthesis tolerance, analgesic consumption, patient-reported improvement, and adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Outcome assessors and statisticians analyzing study data will remain blinded to treatment allocation whenever feasible. Treating clinicians performing ultrasound-guided injections will not be blinded because of differences in PRP preparation and injection procedures. Participants will be informed that they may receive one of two ultrasound-guided injection treatments for chronic neuroma pain.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Combat-related limb amputation
- •Chronic neuroma pain lasting ≥3 months
- •Ultrasound-confirmed painful neuroma
- •Average neuroma pain intensity ≥4/10 on the Numeric Rating Scale
- •Persistent pain interfering with rehabilitation, prosthesis use, or daily activities
- •Ability to undergo ultrasound-guided injection
- •Stable analgesic regimen for at least 14 days before enrollment
- •Ability to provide written informed consent
排除标准
- •Active infection at or near the injection site
- •Open wound preventing safe injection
- •Previous PRP injection for neuroma pain within 6 months
- •Previous neuroma surgery within 3 months
- •Severe coagulopathy or platelet disorder
- •Anticoagulant therapy contraindicating injection
- •Active malignancy
- •Severe uncontrolled systemic disease
- •Known allergy to local anesthetics
- •Inability to complete follow-up assessments
研究者
Dmytro Dmytriiev
MD, PhD, Professor
Ukrainian Society of Regional Anesthesia and Pain Therapy